RecruitingNot ApplicableNCT06601478

Development and Implementation of a Tool for the Evaluation and Monitoring of the Mediterranean Lifestyle in the Clinical Setting

Development and Implementation of a Tool for the Evaluation and Monitorization of Mediterranean Lifestyle At Clinical Settings: MEDLIFE Index, a Proof of Concept Study

Sponsor

Universidad Autonoma de Madrid

Enrollment

80 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

Lifestyle

Summary

The main goal is to develop a health online app based on a Mediterranean lifestyle score (diet, cooking preferences, rest, physical activity, social habits, conviviality) and its implementation in clinical settings with patients that have suffered from a cardiovascular event. This is a pilot study that will allow an integral assessment of health as an attempt to decrease obesity, one of the main risk factors of cardiovascular disease, as well as to improve the prevention of secondary events. The main goal involves the following specific objectives: Developing and transferring the previously validated questionnaire in Spanish population (MEDLIFE index, MEDiterranean LIFEstyle) to evaluate adherence to a Mediterranean lifestyle an online app, that allows: To evaluate and to monitor the adherence to the MEDLIFE throughout time. To use the MEDLIFE online app to obtain customized recommendations according to the results (an instantaneous generation of a resume of results). To start conversations between patient and health workers to improve patient's lifestyles, obesity or related parameters and cardiovascular health. To keep information in a safe way that will allow it to be linked to other health indicators. Conducting a qualitative study using personal interviews with health providers and patients, to evaluate acceptation, feasibility, barriers, or limitations when using the MEDLIFE app in clinical practice, aiming for the app's enhancing. Conducting a pilot study of implementation of MEDLIFE in clinical settings, in patients with a cardiovascular event (myocardial infarction, ictus, angina, ischemic cardiopathy) (n= 80-100, trying parity between men and women). This is the project's intervention part. To evaluate changes in MEDLIFE and its components, anthropometric and biochemical measurements between baseline, 3-month, 6-month and 8-month follow-up. Following participants by means of revision of medical reports and clinical histories to register future cardiovascular events (dynamic).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

Age over 18 years and below 75 years.
Absence of language barriers
To be included in the cardiac rehabilitation programme
Capacity to comprehend, and answer the questionnaires, as well as to sign the informed consent.
Being a Spanish resident for a period of at least 1 year prior to the beginning of the study.
Not planning to permanently reside outside of Spain within the year.
Having suffered from a cardiovascular event (myocardial infarction, ictus, angina, ischemic cardiopathy).

Exclusion Criteria4

Limitation to adhering to the recommendations.
Severe risk factors and/or with complicated control.
Chronic diseases not related to coronary disease (severe mental illness, congenital, susceptible to decompensation endocrinopathies, and gastrointestinal diseases with diarrhoea).
Patients that have an alternative private health insurance that doesn´t allow an electronic access to their data.

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Interventions

BEHAVIORALThe MedLIFE app

The intervention arm will receive the lifestyle counselling by the MEDLIFE app, and the control arm will go on with standard lifestyle recommendations in the form of a two-page written handout.